Compliance: Understanding ISO 13485:2016
An overview of the key portions of ISO 13485:2016 is given in this article. Why was ISO 13485...
Compliance
RoHS: Restriction of Hazardous Substances- Compliance Requirements
Understanding ROHS compliance is essential if you manufacture, import, or distribute electrical and electronic equipment (EEE) for the UK...
FDA 21 CFR Part 11 Compliance: Crucial Factor for Licensed Firm
The use of electronic records and electronic signatures required by predicate regulations governing manufacturing activities is governed by 21...
21 CFR Part 11: Goals, Implication and Importance
21 CFR Part 11 relates to all records covered by FDA regulations that are in electronic form and establishes standards...
Data Integrity: Meeting the Regular Expectation
Basic data integrity issues continue to plague many businesses. The quantity of warning letters and Form 483 inspectional observations at...
The Top 5 Challenges in Developing, Managing and Using Standard Operating Procedures (SOPs) and Solutions
Are you a senior manager in charge of process upgrades in your company? If so, one of the most important...
The Equal Credit Opportunity Act (ECOA): A Key Component of the CFPB’s Part 1002 – Regulation B
Legal prohibitions against discrimination According to the Equal Credit Opportunity Act (ECOA), lenders must treat loan applicants fairly in...
Dietary Supplement Regulations in the United States
The FDA does not approve food, beverages, or dietary supplements in the United States. Pre-market approval is not...
Disclosure and Transparency : Importance
Corporate governance regulations and codes should be built on the principles of disclosure and transparency. Business organizations should communicate their...
Premarket Approval(PMA) for Medical Devices : Data Requirements
A Premarket Approval (PMA) application is a scientific and legal document submitted to the FDA to support the class...
